FDA.reportPublic FDA data

Sterilisation tray

Primary DI
04250337119876
Brand
Sterilisation tray
Company
Joimax GmbH
Model
JSBDSST4680
Catalog number
JSBDSST4680
Device description
Sterilization tray Shrill® Deflector Shaft
Published
2022-12-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KCTSterilization wrap containers, trays, cassettes & other accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123234000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123234000ERMIS STERILIZATION CONTAINER SYSTEMErmis Medizintechnik2013-07-05KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250337119876PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250337119876042503371198764250337119876

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+497212551407010info@joimax.com

Regulatory Flags#

DUNS number
344267187
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250337121657Working Tube with long lipWTS1615172026-08-19
04250337117384video lensCSFHD01COVZCSFHD01COVZ2022-12-30
04260744830561Fibre optic cableCSLC0348CSLC03482022-12-30
04260744831865Fibre optic cableCSLC0252CSLC02522022-12-30
04250337110040intENTS®TNC582810GTNC582810G2022-12-30
04250337110057MultiZYTE®TNC582814GTNC582814G2022-12-30
04250337110064iLESSYS®TNC582820RTNC582820R2022-12-30
04250337113041TESSYS®TNC582820TNC5828202022-12-30
04250337117537tubTNC5828100TNC58281002022-12-30
04250337117544tubTNC5828135TNC58281352022-12-30
04250337117551tubTNC5828150TNC58281502022-12-30
04250337117568tubTNC5828200TNC58282002022-12-30
04250337117575iLESSYS®TNC5828CLTNC5828CL2022-12-30
04250337117582iLESSYS®TNC5828ILTNC5828IL2022-12-30
04250337117599iLESSYS®TNC5828MLTNC5828ML2022-12-30
04250337117605iLESSYS®TNC5828NLTNC5828NL2022-12-30
04250337117612iLESSYS®TNC5828TLTNC5828TL2022-12-30
04250337117827iLESSYS®TNC5828ALTNC5828AL2022-12-30
04250337120759deflectorJSBS311509JSBS3115092025-07-25
04250337120766deflectorJSBS311512JSBS3115122025-07-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00385640094016INSTRUSAFESummit Medical, Inc.KCT2026-08-19
00385640094023INSTRUSAFESummit Medical, Inc.KCT2026-08-19
00385640093972INSTRUSAFESummit Medical, Inc.KCT2026-08-18
00385640093989INSTRUSAFESummit Medical, Inc.KCT2026-08-18
00385640094009INSTRUSAFESummit Medical, Inc.KCT2026-08-18
00724995239879V. MuellerSteris CorporationKCT2026-08-18
00724995239886V. MuellerSteris CorporationKCT2026-08-18
00724995239893V. MuellerSteris CorporationKCT2026-08-18
00724995240615V. MuellerSteris CorporationKCT2026-08-18
00724995240622V. MuellerSteris CorporationKCT2026-08-18
00724995240639V. MuellerSteris CorporationKCT2026-08-18
00724995240714V. MuellerSteris CorporationKCT2026-08-18
00724995240721V. MuellerSteris CorporationKCT2026-08-18
00724995240738V. MuellerSteris CorporationKCT2026-08-18
00724995240745V. MuellerSteris CorporationKCT2026-08-18
00724995240752V. MuellerSteris CorporationKCT2026-08-18
00724995240769V. MuellerSteris CorporationKCT2026-08-18
00724995240776V. MuellerSteris CorporationKCT2026-08-18
00724995240783V. MuellerSteris CorporationKCT2026-08-18
00724995240790V. MuellerSteris CorporationKCT2026-08-18
00724995240806V. MuellerSteris CorporationKCT2026-08-18
00724995240813V. MuellerSteris CorporationKCT2026-08-18
00724995240820V. MuellerSteris CorporationKCT2026-08-18
00724995240837V. MuellerSteris CorporationKCT2026-08-18
00724995240844V. MuellerSteris CorporationKCT2026-08-18
00724995240851V. MuellerSteris CorporationKCT2026-08-18
00724995240868V. MuellerSteris CorporationKCT2026-08-18
00724995240875V. MuellerSteris CorporationKCT2026-08-18
00724995240882V. MuellerSteris CorporationKCT2026-08-18
00724995240899V. MuellerSteris CorporationKCT2026-08-18